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Re: biopharm post# 121545

Wednesday, 05/08/2013 3:59:11 PM

Wednesday, May 08, 2013 3:59:11 PM

Post# of 345745
Here are the EOP2 FDA Guidelines: http://www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf

We are requesting a "Type B Meeting".

Page 13 of the PDF, Section X of the document, says FDA has 30 days to finalize Minutes. Section XI indicates time could go on longer if SK and Garnick disagree with the Minutes and request a clarification, but my understanding is that in most cases the final tweaking and clarifying of the Minutes by both sides happens within the initial 30 days.






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